Management of Asthma in Primary Care - Clinical Center (UG3/UH3 - Clinical Trial Required) | RFA HL 19 005

Opportunity Information: Apply for RFA HL 19 005

This National Institutes of Health (NIH) funding opportunity, titled "Management of Asthma in Primary Care - Clinical Center (UG3/UH3 - Clinical Trial Required)" (RFA HL 19 005), is focused on improving how asthma is managed in real-world primary care settings. The central goal is to figure out which asthma management approaches primary care providers are already using, determine which of those approaches appear to work best based on large-scale patient data, and then test the most promising strategies prospectively in clinical trials that are enabled by electronic health records (EHRs). In other words, it is designed to move from observation (what is currently being done and how well it works) to prospective evaluation (testing selected approaches in a structured way), with EHR systems serving as a key tool for identifying patients, measuring outcomes, and supporting trial operations.

The work supported under this announcement is structured around a Cooperative Agreement mechanism, which generally means the NIH expects substantial involvement and collaboration during the project rather than a hands-off grant. The required award structure is a Clinical Center composed of three coordinated parts. First is a Primary Care Network (PCN), which provides access to a broad and representative set of primary care practices and patients with asthma. Second is a Data Management Core (DMC), responsible for the complex data tasks that come with using EHRs at scale, such as assembling data from multiple sites, standardizing variables, ensuring data quality, and supporting analyses and trial reporting. Third is a Clinical Consultation Center (CCC), which supports clinical expertise and consultation needed to interpret asthma care patterns, align proposed interventions with clinical realities, and help design and conduct the prospective EHR-enabled trials. Taken together, these components are intended to create an end-to-end infrastructure: identify existing care patterns in primary care, evaluate them with rigorous analytics, and then run pragmatic clinical trials within the same healthcare environments.

A major emphasis of the announcement is the use of EHR data from a nationally representative sample of patients. This indicates the project is expected to look beyond a single health system or a narrow patient subset and instead capture variation across geography, practice types, and patient demographics. The initial stage involves analyzing EHRs to identify the asthma management strategies currently in use in primary care, such as medication prescribing patterns, follow-up cadence, use of action plans, referrals, and other routine care decisions. From those real-world patterns, investigators are expected to identify paradigms that appear most effective based on outcomes observable in the EHR (for example, asthma control indicators, exacerbations, emergency visits, hospitalizations, or medication use patterns), and then select strategies suitable for prospective testing. The prospective phase is explicitly described as involving EHR-enabled clinical trials, meaning the trials are meant to leverage routine clinical data and workflows rather than operate as isolated research studies divorced from everyday practice.

The award uses the UG3/UH3 phased approach and requires a clinical trial. In practical terms, this type of structure typically reflects an initial phase focused on planning, feasibility, and building the operational and data infrastructure (UG3), followed by an implementation phase where the full prospective evaluation or trial is carried out (UH3), assuming milestones are met. The "Clinical Trial Required" label signals that applicants must be prepared to conduct an actual interventional study rather than only an observational analysis. The overall activity category is Health, and the CFDA number listed is 93.838.

Eligibility is broad across U.S.-based organizations and includes many types of public and private entities. Eligible applicants include state, county, city or township governments, special district governments, and independent school districts, as well as public and state-controlled institutions of higher education and private institutions of higher education. Eligible tribal entities include federally recognized Native American tribal governments and other Native American tribal organizations (including those other than federally recognized tribal governments). The opportunity is also open to nonprofits (both 501(c)(3) and non-501(c)(3) organizations, as long as they are not institutions of higher education in those categories), for-profit organizations (other than small businesses), and small businesses, along with other eligible organization types. The announcement also explicitly highlights additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.

Foreign participation is specifically restricted. Non-domestic (non-U.S.) entities (foreign organizations and foreign institutions) are not eligible to apply. In addition, non-domestic components of U.S. organizations are not eligible, and foreign components as defined by the NIH Grants Policy Statement are not allowed. This means applicants need to ensure the project leadership, core infrastructure, and supported activities are entirely domestic in terms of eligibility and allowable components.

From an administrative standpoint, the opportunity was posted by the NIH, with an original closing date of October 31, 2018, and a creation date of August 2, 2018. The listed funding instrument type is a Cooperative Agreement, and the opportunity category is discretionary. While an award ceiling and expected number of awards are not provided in the supplied text, the program description makes clear that the NIH intended to fund a coordinated Clinical Center capable of running large-scale EHR analyses and pragmatic, EHR-enabled clinical trials focused on asthma management in primary care settings.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Management of Asthma in Primary Care - Clinical Center (UG3/UH3 - Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.838.
• This funding opportunity was created on 2018-08-02.
• Applicants must submit their applications by 2018-10-31. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for RFA HL 19 005

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